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Coordinating Center Functions and Multi-Site Studies
A Coordinating Center is responsible for overall data management, monitoring and communication among all sites, and general oversight of the conduct of a human subjects research project. A Coordinating Center may be designated either by a sponsor or by mutual agreement of the participating sites.
A JHM Principal Investigator (PI) wishing to act as the Coordinating Center PI for a multi-site research effort must submit an eIRB application for JHM IRB review and approval in which s/he describes the Coordinating Center functions and responsibilities. The PI may submit either of the following:
- For studies in which there will be no subject enrollment at Hopkins – a specific Coordinating Center application and protocol that outline the responsibilities of the Center and the Coordinating PI. This must be submitted to the IRB for review and approval prior to initiating the Center’s functions.
- For studies in which there will be subjects enrolled at Hopkins – an application and protocol in which the JHM PI outlines the conduct of the research with participants at Hopkins. In such cases, a specific Coordinating Center protocol may or may not be available as a separate protocol submission. If not, the Coordinating Center functions should be described in protocol submitted or in a sub-protocol. The IRB will review the application materials submitted to determine if the Coordinating Center functions are described.
In either case, the JHM IRB of record will confirm that the following are addressed by the PI in the application:
- Confirmation that the Coordinating Center PI has contact information for all centers;
- A plan for review of each center’s IRB approval documents and consent forms;
- Confirmation that each participating center has on file an FWA with OHRP (if the research is federally funded)
- A method for assuring that all centers have the most current version of the protocol and that amendments to the protocol will be communicated to all centers
- A plan for collection and management of data from all centers
- A process for reporting and evaluating protocol events and deviations from participating centers.
Multi-center and multi-site refer to a project that will be conducted at Hopkins/Affiliates and non- Hopkins/Affiliates locations. The JHM IRB defines a multi-center study as a clinical trial that is written to include conduct of a model protocol carried out at more than one medical institution. As part of the application, the PI shall disclose to the JHM IRB who will serve as the coordinating center for the project.
A multi-site study is defined as a study in which the JHM investigator is conducting research at a site(s) not affiliated with the Organization. Examples include public elementary schools, nursing homes, independent health care facilities, private practices, etc. The following information must be provided in the eIRB application for studies for which the JHM IRB will serve as the IRB of record for conduct at one or more non-Hopkins sites:
- Name and address of the site
- Name of the contact at the site
- Contact information (phone and email)
- Whether the site provided permission to conduct the research at that site
- Whether the site has an IRB
- Whether the site’s IRB has approved the research
- Whether the site is an international site, and if so, whether it has an FWA (for federally funded studies)
If the site is engaged in the research, either its IRB must approve the conduct at the site or a research review agreement for reliance on a JHM IRB must be executed with JHM. Investigators who wish to pursue a review agreement for this purpose should contact the Senior Administrative Coordinator to the Assistant Dean in the Office of Human Subjects Research (OHSR).
Final approval will be withheld until the JHM IRB and the OHSR have all required documentation on file.
If any problems arise with external sites, IRB staff will communicate with the contact person named in the application if necessary.
Department of Defense funding and multi-center research
Multi-center research conducted with Department of Defense funding awarded to JHM will require a formal agreement be executed between JHM and the organizations serving as study sites. The agreement must specify the roles and responsibilities of each party. The agreement must be in place before an investigator may begin an IRB-approved, multi-center research project for which Hopkins is the lead center.